Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Basel, 26 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Julie Brown has notified the Board that she will step down as a member of the Roche Board of Directors as she has accepted a management role at another pharmaceutical company. This change will be effective from today.

Change in the Roche Board of Directors

Roche's new compact and modular system is designed to simplify daily operations, increase lab productivity, and support the delivery of better patient care through automation of manual tasks. cobas® pure integrated solutions brings together three diagnostic technologies on a single platform to optimize space and resources in low- to mid-volume laboratories.

Roche granted FDA clearance for cobas pure integrated solutions for low- to mid-volume laboratories

The European Commission approves Roche's (RHHBY) Vabysmo for treating neovascular or wet age-related macular degeneration and visual impairment due to diabetic macular edema.

Roche's (RHHBY) Vabysmo Gets Approval for nAMD & DME in Europe

Roche Holding AG said Monday that its vision-loss treatment Vabysmo has been approved in the European Union after successful phase-3 study data.

Roche's vision-loss drug Vabysmo gets EU nod

Basel, 19 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) approved Vabysmo® (faricimab) for the treatment of neovascular or ‘wet' age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people 1,2,3,4

European Commission approves Roche's Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Roche bottomed on June 16, reached my previously set target, and is forming a sound base from which it could attempt to break out. The stock is a leader in its industry despite underperforming the broader healthcare sector, which has been performing well in the past 3 months.

Roche Is Trying To Break Out (Technical Analysis)

AstraZeneca

Eli Lilly

Shares in pharmaceutical giants including Roche, Novo Nordisk, Eli Lilly and AstraZeneca were little changed Wednesday despite getting a ratings boost from analysts at Berenberg, who cited respective returns on research and development investment and the ability of those companies to withstand pressure coming from recent U.S drug price reform.

AstraZeneca, Eli Lilly and Roche among pharmaceutical companies upgraded for high returns on R&D investments, analysts say

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo.

Roche's VENTANA PD-L1 (SP263) Assay receives CE IVD approval to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

SEATTLE--(BUSINESS WIRE)--Good Therapeutics, a privately held company, today announced it has entered into a definitive merger agreement to be acquired by Roche (SIX: RO, ROG; OTCQX: RHHBY). With this acquisition, Roche will gain rights to Good Therapeutics' innovative, conditionally active, PD-1-regulated IL-2 program and an exclusive right to the platform technology for the development of PD-1-regulated IL-2 receptor agonist therapeutics. Under the terms of the merger agreement, Roche will ma

Good Therapeutics Announces Acquisition of Conditionally Active PD-1-regulated IL-2 Program by Roche

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study. 1 This label expansion strengthens Roche's industry-leading portfolio of companion diagnostics and builds on its commitment to improve personalised healthcare for better patient outcomes.

Roche's VENTANA PD-L1 (SP263) test gains CE label expansion as a companion diagnostic to identify non-small cell lung cancer patients eligible for Tecentriq

Basel, 23 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Digital LightCyclerⓇ System, Roche's first digital polymerase chain reaction ( PCR) system. This next-generation system detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods.

Roche launches a digital PCR system, a powerful new diagnostics platform in the fight against cancer and other diseases

Roche has developed a COVID-19 test for researchers that detects the latest subvariant BA.2.75 and can differentiate it from BA.4 or BA.5 This new test is a highly accurate tool that specifically targets mutations found in the BA.2.75 subvariant - providing important epidemiological insights in monitoring the potential impact of therapeutics, vaccines, and public health interventions PLEASANTON, Calif. , Aug. 22, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed a  COVID-19 test for researchers that detects and differentiates the latest subvariant of interest BA.2.75.

Roche launches COVID-19 test that detects and differentiates the emerging variant of interest BA.2.75

Roche's (RHHBY) sBLA seeking approval for the use of Polivy in combination with R-CHP for previously untreated diffuse large B-cell lymphoma in adults has been accepted in the United States.

Roche's (RHHBY) sBLA For Polivy Combo Accepted by FDA

Basel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 2 April 2023. “The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.” DLBCL is an aggressive blood cancer. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those who require subsequent lines of therapy have poor outcomes. The sBLA is based on results from the pivotal phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p

FDA accepts supplemental Biologics License Application for Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is

FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

Basel, 15 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys® IGRA SARS-CoV-2 test in countries that accept the CE Mark1. The Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection and vaccination. The test will be an additional tool to make better-informed decisions around care, sanitary measures and treatment options. This will be particularly important for at-risk patient groups.

Roche launches new diagnostic test for the better understanding of immune response to SARS-CoV-2

Roche (RHHBY) obtains FDA approval for expanded indication of influenza drug Xofluza.

Roche (RHHBY) Influenza Drug Gets FDA Nod for Children

Basel, 12 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine approved in the US for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine

Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older

Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial cancer patients, for treatment with Merck's immunotherapy KEYTRUDA. The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.

Roche receives FDA approval for VENTANA MMR RxDx Panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for KEYTRUDA

Poseida Therapeutics

Source: Shutterstock Poseida Therapeutics (NASDAQ: PSTX ) stock is soaring on Wednesday after the clinical-stage biotechnology company announced a deal with Roche (OTCMKTS: RHHBY ). The agreement with Roche will have it working with Poseida Therapeutics to develop “allogeneic CAR-T therapies directed to hematologic malignancies.

Poseida Therapeutics (PSTX) Stock Rockets 79% on Roche Deal

Basel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq® (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq.

Roche's subcutaneous formulation of Tecentriq demonstrates positive Phase III results

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq® (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-sma

Genentech's Subcutaneous Formulation of Tecentriq Demonstrates Positive Phase III Results

The company has posted growth despite lower demand for several key products.

How This Multibillion-Dollar Company Is Shaking Off the Competition

Basel, 28 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from 41 abstracts across its portfolio of Alzheimer's disease pharmaceuticals and diagnostics will be presented at the 2022 Alzheimer's Association International Conference (AAIC), which will be held in San Diego 31 July -4 August. Among the data are new presentations on Roche's investigational subcutaneously administered anti-amyloid monoclonal antibody gantenerumab and the Elecsys® Amyloid Plasma Panel. Additionally, detailed results from the Alzheimer's Prevention Initiative Autosomal Dominant Alzheimer's Disease (API ADAD) Trial evaluating the investigational monoclonal antibody crenezumab will be presented to inform future Alzheimer's prevention research.

News for Roche Holding AG Stock (RHHBY)